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Dr Simone Plastic Surgeon Sydney will continue to update this document as new evidence comes to light. This article aims to present the data we have as of the end of March 2019. There has been a lot of talk in the media about breast implant illness and cancer associated with breast implants. With so many highly publicised breast implant problems in the past, it is hard for patients to distinguish real facts from hysteria.

There was the silicon scare in the nineties, which saw breast implants taken off the market without any scientific proof they were causing problems. This drove multi-centre trials of large numbers of women which demonstrated no link between silicon and various illnesses. Illogically, saline implants with a silicon shell remained on the market in the USA during this time, leading to poorer cosmetic outcomes and exposure to silicon anyway. The anti-silicon wave of the early nineties was driven more by the atmosphere of litigious greed rather than good science.

This was followed by the PIP scare, where a specific brand of implants produced in France showed the implants were produced with silicon that was not medical grade and may have had a higher rate of rupture. The TGA eventually released a statement there was no real evidence in the absence of leakage that they caused harm and did not require routine removal. Other materials such as soybean oil were briefly tried and quickly taken off the market due to ruptures and leakage.

The controversy has been reignited today with increasing numbers of women reporting non-specific debilitating symptoms they attribute to their breast implants which has been given the term “Breast implant illness”.

The first thing to note is that currently, there is no scientific evidence to back up the existence of any chronic illness that is associated with breast implants or that they can make you generally unwell. Whilst many of the symptoms patients experience may be real, there is no evidence to suggest breast implants are the cause. Symptoms described in breast implant illness are wide ranging such as tiredness, cognitive issues, connective tissue disease, reproductive problems or muscle pain.

It is important to distinguish between “Breast implant illness” and breast implant associated lymphoma or BIA-ALCL. Currently there is no link between the two. Breast implant illness does not lead to ALCL. Breast implants illness has no blood test, immune or other markers that can be tested for. BIA-ALCL has very changes and markers that are present in the rare cases of this disease and can be tested for.

Breast implant associated illness

What breast implant illness is not…

Distinguishing specific localised problems associated with breast implants and “breast implant illness”

There is no doubt some patient can experience real problems with their breast implants. And in some of the examples below, removal of the breast implant can help with these.

A significant breast implant rupture or capsular contracture (formation of excessive hard scar tissue around the implant) can lead to pain in the breast or pain referred to adjacent areas. Performing a removal in this situation can definitely improve symptoms. Older leaking implants are better off with a capsulectomy as the scar tissue is stiff and can lead to areas of firmness in the breast and there may be silicon leakage into the surrounding tissues

A mobile implant that has not adhered properly and moves with muscle contraction or has “bottomed out” (ended up below the native inframammary fold or crease) can also cause discomfort.

A rupture or tear if subclinical and not causing symptoms is not dangerous. MRI can report a rupture when one is not present intraoperatively and sometimes an MRI can also miss a small rupture. Modern breast implants have silicon that has a firm jelly baby-like consistency; they are encased by a capsule and most ruptures that occur with modern implants are considered “intracapsular”. This means the silicon does not leak anywhere and is not dangerous.

What is an en bloc capsulectomy and is it necessary with all breast implant removals?

An en bloc capsulectomy means taking the entire capsule and breast implant out in one piece. tissue.

In cases of very old, ruptured silicon implants there can often be silicon leakage into the surrounding tissues and the capsule can be very thick or hard. In these situations it is better to remove the implant and capsule en bloc.

However, taking out an entirely normal capsule en bloc in the event of an implant placed more recently that has not leaked is not necessary. It requires a larger incision (up to 10cm) and removal of the capsule can be difficult and take normal breast tissue with it. En bloc capsulectomy is unnecessarily aggressive in patients without the above-mentioned problems. In any case, you cannot guarantee that every last piece of capsule is taken. It is a myths that the capsule contains nasties or is toxic in the absence of leakage or the very rare case of cancer; it is mostly the body’s own scar tissue.

There is no evidence removing the capsule and the implant will cure breast implant illness.  In fact. removing the capsule can increase the risk of numbness or damage to the fine nerves in the surrounding tissues.

In those hoping for a fat transfer as a means of reconstruction, it is best to leave the capsule as it is a layer of tissue which can be grafted to. Taking out normal scar tissue just creates more scar tissue.

Can removing the breast implant and capsule cure breast implant illness?

 There is no doubt some women report relief of some of the symptoms they perceive to be “breast implant illness” upon their removal. However, as there are no objective markers that change after removal, it is hard to prove how much the operation had an actual effect and what is placebo.

Many women see no improvement in their symptoms after removal. No surgeon should promise cure of symptoms with removal of implants with a partial, total or en bloc capsulectomy.

While it is up to the individual whether they want their implants and capsule out, it is important they are informed they are essentially doing something which has no evidence that it will be curative or improve their symptoms in any way. Currently it is not possible to predict which women may improve with removal and those that will not prior to explant surgery. So beyond peace of mind that the implants are no longer present there is no guarantee of curing any of the breast implant illness symptoms.

Breast Implant associated Anaplastic Large Cell Lymphoma (BIA-ALCL)- What we know so far

The FDA first identified a possible association between breast implants and the development of ALCL in 2011, although isolated cases were reported before this as early as 2007.  With so few cases initially diagnosed, it was difficult to determine risk factors.

Now with over 600 cases worldwide (and an estimated 35 million breast implants that have been placed) we still do not have all the answers.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL is not a cancer of the breast tissue itself but the capsule that develops around implants. The capsule is the body’s own scar tissue that forms in response to placement of any foreign body. Capsules can be thin as is the case with most modern implants which have a reduced rate of capsular contracture compared to earlier models. Capsular contracture occurs when excessive scar tissue forms around the implant and shortens or contracts, distorting the implant. When severe it can lead to pain and significant aesthetic problems. Capsular contracture is not a risk factor for BIA-ALCL.

BIA-ALCL numbers and facts

There have been 689 cases of ALCL to date worldwide as of March 18, 2019.

76 of these cases have been in Australia.

These numbers are a combination of patients with their first set of breast implants or those who have had one or more removal and replacements.

Half of the reported cases were diagnosed within 7-8 years of implant placement. The range from time to implantation to diagnosis is 0.8-27 years. Average time to diagnosis is 9.2 years from the insertion.

Most patients who develop BIA-ALCL have had textured implants.

There have now been reported cases of BIA-ALCL in patients with smooth-surfaced implants.

Some of the reports haven’t included surface texture of the implant at the time of diagnosis.

Both silicone gel and saline implants have been reported in cases of BIA-ALCL.

Both cosmetic breast augmentation as well as breast reconstructions have had BIA-ALCL diagnosed.

Current literature reports various estimates for the incidence of BIA-ALCL. These range from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000. As more cases come to light these statistics will change.

Most of the patients who have developed BIA-ALCL have an excellent prognosis following surgical removal of the breast implants and the surrounding capsule.

There have been nine deaths associated with BIA-ALCL.

Symptoms and signs of  BIA-ALCL- how it commonly presents

Overwhelming majority of patients that have been unfortunate enough to get BIA-ALCL have presented with a change in their breast implant or surrounding tissues that is visible to them.

The most common presenting symptom is a large delayed onset fluid collection around the implant, called a seroma. It is usually big enough to notice a change in size of the implant.

Other symptoms include new swelling or lumps around the breast implant, skin rashes, enlarged lymph nodes, fevers and night sweats.

It is diagnosed by taking out the fluid around the implant and sending it for a special immunohistochemistry marker know as CD-30 (which is on T-cells).

In patients who present with any risk of lymphoma, the capsule is sent for analysis of CD30 at the time of surgery.

Total capsulectomy and removal of implants is the recommended treatment in cases of BIA-ALCL.

The cancer is found in the capsule and surrounding breast implant fluid. Only 10-15% have masses that are more invasive.

Most patients have been cured of disease; some may require radiotherapy and chemotherapy

BIA-ALCL spontaneous regression and apparent resolution has occurred in two cases.

What is causing BIA-ALCL? 

An interaction between genetics, implant surface and possible inflammation are thought to be potential causative factors.

 There is ongoing research being done on this as more numbers come to light.

Current evidence from peer-reviewed literature does not permit to establish any significant link between BIA-ALCL development and any type of patient or any surgical techniques.

BIA-ALCL and textured implants 

BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

Certain types of rougher or heavier texturing may be implicated more than other textured implants.

BIA-ALCL and polyurethane implants

There are articles that quote and present different ratios for the risk of developing BIA-ALCL for polyurethane implants in Australia and are not backed by adequate numbers and clinical evidence.

A meaningful incidence rate is given by the ratio between new cases that occurred during a precise time frame (numerator) and the real population at risk or the true sales figures (denominator) during the same period. The sales figures in the recent literature took into account only polyurethane implants sold by one manufacturer which no longer distributes in Australia. The sales of the main polyurethane distributor (produced in Germany) were excluded and therefore the risk overestimated.

The German distributor has had only 2 cases of lymphoma in a polyurethane implant. All other cases were reported with a polyurethane distributor that uses a different manufacturing process that lost its CE approval in 2015. They use a different production method to the German manufacturer and are not the same implant and should not be considered in the same category.

At this stage there are no real statistics to support the inflated rate of ALCL reported with some case series related to polyurethane implants. The statistics are based on incomplete sales data which do not include the German manufacturer.

Textured implants were developed to mimic the shape and the benefits of the polyurethane foam. It is a very common conceptual mistake to consider polyurethane coated implants as textured implants. The polyurethane foam is a three-dimensional matrix that provides a completely different surface. The mechanisms related to tissue adhesion as well as to fibrous capsule formation differs substantially from those of textured implants.

Is there any implant that does not carry a risk of lymphoma?

According to the current scientific knowledge available on this topic, it is not possible to claim that any kind of implant (including the smooth ones) will never face BIA-ALCL issues due to specific characteristics of the implant.

One has to be careful of marketing of newer implants using buzzwords such as “nanotextured” with only a few years on the market. One must remember that ALCL is diagnosed an average of 9 years after implant placement. It takes several years to develop, therefore, conclusions about the safety of newer implants cannot be made.

This entity only appeared in 2007 despite the fact the first breast implant was placed in 1969. And unfortunately, as yet, we do not have all the answers.

Real scientific research with high level clinical data takes several years across multiple centres around the world.  The risk still remains extremely low and capsular contracture and other implant problems are much more likely to occur.

It is difficult to collect data as plastic surgeons all use their own techniques which vary slightly from centre to centre, and different implants. There is no single way to perform breast augmentation; and different methods can all work to achieve people’s surgical goals. This, however, makes gathering comparative data extremely difficult.

Plastic surgeons continue to update the FDA, TGA and patients as more data comes to light.

No device or procedure can ever be guaranteed as 100 per cent safe. We can only go by what the best evidence is at the time.

This article attempts to present the current facts and make conclusions from those; nothing is definitive until more data becomes available. Dr Simone Matousek has no particular affiliation with any implant company financially or otherwise. She has placed all types of breast implants during her career from different companies.

Most things in life are not without risk. Breast implants have the ability to significantly improve quality of life in certain individuals. Whether a patient wishes to accept a statistically small risk of an implant placement potentially leading to a rare cancer is entirely up to them. It is a listed risk factor in all surgery consent forms now.

If you are concerned at all about any changes in your implants it is important you seek medical attention and investigation. Routine monitoring or imaging of patients with breast implants without symptoms or discernible changes is not required.

TGA update on breast implants as of the 9th of April, 2019

Thankfully the TGA has decided not to follow the French decision to ban textured implants while they properly re examine the scientific evidence.

It is important to note that BIA-ALCL is exceedingly rare. The most common problem seen with breast implants is capsular contracture. Textured implants have played a very important role in lowering the rates of capsular contracture.

Not all textured implants are the same. All brands and even smooth implants have also had reported cases. Smooth implants have much higher rates of capsular contracture and re operation than textured implants.

It is important to understand the differences in numbers between specific types of textured implants and brands. More figures are coming to light that will better separate these differences.

The current international consensus is that there is no evidence supporting removal of breast implants in the absence of properly diagnosed BIA-ALCL.

However, no one can guarantee zero risk of BIA-ALCL with any device. It is important patients make an informed decision as to if they are willing to accept the small risk of a rare cancer for a reconstructive or cosmetic operation.

Here is a full link to the current TGA document.

As a result of the TGA reviewing all current evidence, no breast implants have been banned in Australia.

Update from editorial in leading Plastic and Reconstructive surgery Journal May 2019

“Not all implants are created equal.”

In the most recent issue of the plastic surgery journal there is an update on the current statistics with regards to certain breast implants deemed high risk. Full link to article is here.

It has been found that there is a difference in manufacturers then it comes to implant risk.  The German brand of polyurethane implants (currently the only polyurethane implants available in Australia) only carries a risk of 2 in 400 000. This is the lowest incidence currently known for any textured implant on the market.

It appears there may have been a manufacturing issue for a time with another brand which is no longer available. Even so, the overall risk still remains low and a change in a breast implant needs to be investigated.

Polyurethane implants carry a significantly reduced risk of capsular contracture and are an excellent solution for patients who have experienced this with and are having a revision breast implant. For primary surgery they also have features which mean patients can return to exercise early and carry almost no risk of rotation or capsule for at least ten years.

It is important not to discount any brand of implant while there are low numbers of this cancer. Some brands may not have been in the market for long enough to have seen any cases of BIA-ALCL. Smooth round implants which carry the lowest risk also give the least desirable results in many cases.

Dr Simone does not receive any royalties from any implant manufacturer. She has placed all implant brands and tailors surgery to suit the individual.